Nevirapine Levels and Fluconazole

This study has been completed.
Sponsor:
Information provided by:
Bamrasnaradura Infectious Diseases Institute
ClinicalTrials.gov Identifier:
NCT00309582
First received: March 30, 2006
Last updated: NA
Last verified: November 2005
History: No changes posted
  Purpose

Nevirapine (NVP)-based antiretroviral therapy (ART) has been commonly used in many developing countries due to its affordability and feasibility. Nonetheless, the potential drug-drug interaction between NVP and fluconazole (FLU) is a major concern. NVP can induce cytochrome P450 isoenzymes in the liver while FLU inhibit the activity of this enzyme. The recent report has demonstrated that fluconazole significantly raises plasma NVP levels and may cause serious hepatotoxicity. Conversely, NVP does not significantly influence the plasma level of FLU. However, there have not been enough data or any recommendations to adjust NVP dosage for the concurrent use of both drugs in order to avoid the adverse events. A previous study has demonstrated that genetic disposition may play a role in NVP hypersensitivity reactions. There is little data of safety and tolerability for concurrent use of NVP and FLU in Asian populations. We therefore conducted this prospective observational study to compare the trough plasma NVP levels and frequencies of adverse events among antiretroviral HIV-infected patients who did not receive FLU and received FLU in different dosages for cryptococcosis prophylaxis or treatment; and subsequently received NVP-based ART regimens.


Condition
Nevirapine
Fluconazole
Adverse Event

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Plasma Nevirapine Levels and Adverse Events Among HIV-Infected Patients Concurrently Receiving Nevirapine-Based Antiretroviral Therapy and Fluconazole

Resource links provided by NLM:


Further study details as provided by Bamrasnaradura Infectious Diseases Institute:

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV-infected patients >15 years of age,
  2. naïve to antiretroviral therapy,
  3. were initiated with a NVP-based ART regimen,
  4. used NVP 200-mg once-daily lead-in dose, prior to escalation to 200 mg twice daily.

Exclusion Criteria:

  1. creatinine level was higher than 2.0 mg/ml
  2. liver aminotransferase enzyme was higher than five times of upper normal limit
  3. receiving a medication that has drug-drug interactions with NVP or FLU
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00309582

Sponsors and Collaborators
Bamrasnaradura Infectious Diseases Institute
Investigators
Principal Investigator: Weerawat Manosuthi, MD Bamrasnaradura Infectious Diseases Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00309582     History of Changes
Other Study ID Numbers: BIR2405
Study First Received: March 30, 2006
Last Updated: March 30, 2006
Health Authority: Thailand: Ministry of Public Health

Additional relevant MeSH terms:
Fluconazole
Nevirapine
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 11, 2014